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IVDR

IVDR State of the Art (SOTA)

— coauthored by Heike Moehlig-Zuttermeister, PhD, RQM+ VP Intelligence and Innovation - IVD and Carlos Galamba, RQM+ VP Intelligence & Innovation - IVD  State of the art (SOTA) is a key piece of the IVDR puzzle. Like many of the other required elements, it touches multiple sections of your technical documentation and must be consistently addressed throughout.
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EU | IVDR

What You Need to Know About Significant Changes Under IVDR

Co-authored by Carlos Galamba, RQM+ Vice President, IVD Intelligence and Innovation Until recently, many IVD manufacturers were able to make changes to the design or intended use of their devices with minimal consequences under IVDD (98/79/EC). With the transition to IVDR and the date of application just around the corner, that time window is quickly closing. As of 26 May 2022, IVD manufacturers will no longer be able to make changes to the intended purpose or design of a device under IVDD, and all classes of IVDs will be subject to IVDR regulations.
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IVD | IVDR

Just Released: MDCG Guidance 2022-3 Verification of Manufactured Class D IVDs by Notified Bodies

The MDCG guidance 2022-3 Verification of manufactured class D IVDs by notified bodies was issued earlier this week on the 15th of February 2022. This guidance is important for manufacturers because it provides a detailed specification of the requirements for the testing plan and agreements for batch verification that must be in place between manufacturers, Notified Bodies (NBs) and EU Reference Laboratories (EURLs) to maintain a Class D product on the EU market. Without a successful batch verification process a Class D products is not permitted to be placed on the EU market.
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IVD | COVID-19

EU Update: Expert Panel Views for SARS-CoV-2 Devices

The first three Performance Evaluation Consultation Procedure (PECP) views have been published for a professional SARS-CoV-2 immunoassay and a professional nucleic acid testing (NAT) assay as well as a near-patient testing NAT SARS-CoV-2 product. Considering the actual criticality of these devices, these expert panel views are a big milestone to speed up conformity assessment work conducted by notified bodies (NB) to achieve In Vitro Diagnostic Regulation (IVDR) CE marking.
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